DHX-70H, XTG-70H— 510(k) K221587

Substantially Equivalent

Digimed Co., Ltd.

FDA 510(k) clearance K221587 for DHX-70H, XTG-70H, Substantially Equivalent on 2023-03-03. Applicant: Digimed Co., Ltd.. Device class: 2.

Clearance details

Applicant: Digimed Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2022-06-01
Decision date: 2023-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.